Latest From Cole Werble
COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.
Multiple simultaneous sponsors, foreshortened regulatory reviews, and a packet of unanswered post-approval efficacy issues make for what should be very competitive – and inherently comparative – post-market assessment period for the upcoming SARS-CoV-2 vaccines.
US FDA asks oncology drug sponsors for information on the impact of modifications to clinical trials during the pandemic – with close attention to remote monitoring and data collection.
AstraZeneca devoted a surprisingly large piece of its testimony at the recent House vaccine hearing to its therapeutic work. The company appears to be anticipating another shift in public attention back to the mAB cocktail as a way to treat and prevent COVID-19.
The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.